Insulin detemir - Biologic Drug Details

Summary for insulin detemir

Tradenames:	1
High Confidence Patents:	14
Applicants:	1
BLAs:	1
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for insulin detemir
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin detemir

Recent Clinical Trials for insulin detemir

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of California, Los Angeles	Phase 2
First Affiliated Hospital Xi'an Jiaotong University	N/A
Hennepin Healthcare Research Institute	N/A

See all insulin detemir clinical trials

Recent Litigation for insulin detemir

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all insulin detemir litigation

Pharmacology for insulin detemir

Ingredient-type	Insulin
Established Pharmacologic Class	Insulin Analog

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insulin detemir Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin detemir Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,220,155	2026-07-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,357,616	2037-11-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,376,652	2037-02-24	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	11,097,063	2039-01-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	11,311,679	2025-01-21	Company disclosures

3) Low Certainty: US Patents for insulin detemir Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,016,338	2033-03-11	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,241,117	2032-04-18	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,251,957	2031-06-02	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,265,291	2035-07-15	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,328,157	2035-07-15	Patent claims search

International Patents for insulin detemir

Country	Patent Number	Estimated Expiration
Denmark	1003581
Finland	117055
World Intellectual Property Organization (WIPO)	9938554
World Intellectual Property Organization (WIPO)	0119434
Yugoslavia	46857

Supplementary Protection Certificates for insulin detemir

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2004C/020	Belgium		PRODUCT NAME: INSULIN DETEMIR; AUTHORISATION NUMBER AND DATE: 56370 01 20040601
04C0020	France		PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
122004000035	Germany		PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601 FIRST REGISTRATION: LIECHTENSTEIN 5637001 5637101 5637201 20031110
2004/015	Ireland		PRODUCT NAME: INSULIN DETEMIR; NAT REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION NO/DATE: CH 56370 56371 56372 20031110; PAEDIATRIC INVESTIGATION PLAN: P/0172/2014
PA2004005	Lithuania		PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601

Market Dynamics and Financial Trajectory for Insulin Detemir

Introduction to Insulin Detemir

Insulin detemir, a long-acting insulin analog, is a crucial component in the management of diabetes, particularly for patients with type 1 and type 2 diabetes. This biologic drug is designed to provide a steady, basal insulin supply, helping to regulate blood sugar levels over an extended period.

Market Growth and Forecast

The market for insulin detemir is poised for significant growth, driven by several key factors:

Rising Prevalence of Diabetes

The global prevalence of diabetes is expected to increase substantially, with projections indicating that by 2045, there will be 438 million people between 20-64 years suffering from diabetes. This rise in diabetes cases, particularly among the aging population, is a major driver for the demand of long-acting insulins like insulin detemir[1].

Increasing Geriatric Population

The geriatric population, which is at a higher risk of developing type 2 diabetes due to impaired pancreatic islet function and increasing insulin resistance with age, is growing. For instance, the geriatric population in Europe is expected to increase from 9.3% in 2020 to around 16.0% by 2050, contributing to the market growth[1].

New Product Launches and R&D

Continuous research and development in insulin therapies, including the launch of new products and innovative delivery systems, are driving the market forward. These advancements aim to improve the efficacy and convenience of insulin administration, attracting more patients and healthcare providers to long-acting insulins like insulin detemir[1][3].

Market Size and CAGR

The insulin detemir market is valued at USD 3.7 billion in 2023 and is projected to reach USD 6.9 billion by 2031, growing at a CAGR of 8.4% from 2024 to 2031. This growth rate is indicative of the increasing demand for effective and long-lasting insulin therapies[4].

Regional Outlook

Europe

Europe dominates the long-acting insulin market, including insulin detemir, due to the presence of major pharmaceutical companies and a high geriatric population. More than 20% of Europe's total population is above the age of 65, which significantly contributes to the demand for long-acting insulins[1].

North America

North America, particularly the U.S. and Canada, is another significant region for the insulin detemir market. The region boasts advanced healthcare infrastructure and a strong presence of major pharmaceutical players, driving market growth through acquisitions and collaborations[1].

Product Segmentation

By Product Type

Insulin detemir is one of the key product types in the long-acting insulin market, alongside insulin glargine and insulin degludec. Each of these products has its own set of characteristics and user bases, with insulin detemir being known for its flexibility in dosing and lower risk of hypoglycemia[1].

By Indication

Insulin detemir is used for both type 1 and type 2 diabetes management. The rising prevalence of both types of diabetes globally is a key factor driving the demand for this product[1].

By Delivery Method

Insulin detemir can be administered via various delivery methods, including pumps, needles and syringes, pens, and injection ports. The convenience and flexibility of these delivery methods contribute to the product's popularity[1].

Financial Outcomes and Cost Analysis

Clinical and Financial Outcomes

Studies have shown that switching from insulin glargine to insulin detemir can result in cost savings. For instance, a study involving veterans with type 2 diabetes found that the monthly insulin costs decreased by 19% when switched from glargine to detemir, despite an increase in A1c levels and total daily dose[2].

Market Revenue

Insulin detemir generates significant revenue, with Levemir, a brand name for insulin detemir, generating $649 million in revenue in 2022 alone. This revenue is expected to grow as the market expands and more patients adopt long-acting insulin therapies[5].

Competitive Landscape

The long-acting insulin market, including insulin detemir, is highly competitive with several major players. The competitive landscape is characterized by strategic acquisitions, collaborations, and the launch of new products. Companies are focusing on developing innovative insulin delivery systems and expanding their market presence through various distribution channels[1].

Market Drivers and Restraints

Market Drivers

• Increasing Prevalence of Diabetes: The escalating number of diabetes cases globally is a primary driver.
• Aging Population: The growing geriatric population increases the demand for long-acting insulins.
• New Product Launches: Continuous innovation in insulin therapies drives market growth.
• Public Awareness: Growing awareness about diabetes management and insulin therapy contributes to market expansion[1][3].

Market Restraints

• Health Funding: Inadequate health funding, especially in emerging regions, hampers market growth.
• Diagnostic Limitations: High costs associated with diagnostics and treatment pose challenges, particularly in low-income regions[3].

Top Trends in the Market

Innovative Delivery Systems

The introduction of innovative insulin delivery systems, such as pens and pumps, is a significant trend. These systems enhance the convenience and efficacy of insulin administration, making long-acting insulins like insulin detemir more appealing to patients[3].

Growing Public Awareness

Increasing public awareness about diabetes management and the benefits of insulin therapy is another key trend. This awareness is driven by educational campaigns and the efforts of healthcare providers to educate patients about the importance of glycemic control[3].

Macroeconomic Factors

Economic Stability and GDP Growth

Economic stability and GDP growth directly impact healthcare expenditure, including spending on diabetes management and insulin therapy. Government healthcare policies and reimbursement systems also play a crucial role in shaping market dynamics[3].

Demographic Trends

Demographic trends such as aging populations, urbanization, and lifestyle changes contribute to the increasing prevalence of diabetes, driving demand for human insulin and long-acting insulins like insulin detemir[3].

Key Takeaways

• The insulin detemir market is expected to grow at a CAGR of 8.4% from 2024 to 2031.
• The rising prevalence of diabetes and the increasing geriatric population are key drivers of the market.
• Europe and North America are the dominant regions for the insulin detemir market.
• Innovative delivery systems and growing public awareness are significant trends driving market growth.
• Despite growth drivers, the market faces restraints such as inadequate health funding and diagnostic limitations.

FAQs

What is the projected market size for insulin detemir by 2031?

The insulin detemir market is expected to reach USD 6.9 billion by 2031[4].

Which regions dominate the insulin detemir market?

Europe and North America are the dominant regions for the insulin detemir market, driven by the presence of major pharmaceutical companies and advanced healthcare infrastructure[1].

What are the primary drivers of the insulin detemir market?

The primary drivers include the rising prevalence of diabetes, increasing geriatric population, new product launches, and increasing research and development in insulin therapies[1][3].

How does the cost of insulin detemir compare to other long-acting insulins?

Switching from insulin glargine to insulin detemir can result in cost savings, despite potential increases in A1c levels and total daily dose[2].

What are the major restraints facing the insulin detemir market?

The major restraints include inadequate health funding, diagnostic limitations, and the high cost associated with diagnostics and treatment, particularly in low-income regions[3].

Sources

1. Fact.MR: Long-Acting Insulin Market Size, Share & Trends Report.
2. PubMed: Clinical and financial outcomes of switching insulin glargine to insulin detemir.
3. GlobeNewswire: Human Insulin Market Size to Surpass USD 46.7 Billion by 2033.
4. Market Research Intellect: Insulin Detemir Market Size, Share and Growth Analysis [2031].
5. Carilion Clinic: Levemir No More, Race in Research, Improv, Post Traumatic Growth.